Ulcerative colitis

Organovo Presents FXR314 3D Human Tissue Model Findings That Show Improved Epithelial Barrier Function and Fibrosis Reduction at Crohn’s and Colitis Congress

Retrieved on: 
Thursday, January 25, 2024
Probability, Biology, Fibrosis, Organovo, SAN, Tissue, IBD, Inflammatory bowel disease, Cirrhosis, Research and development, Disease, 3D, NASH, Colitis, Ulcerative colitis, FXR, Pharmaceutical industry

FXR314 is a clinical-stage potent, selective, orally administered non-bile acid FXR agonist being developed as a novel therapeutic approach for IBD.

Key Points: 
  • FXR314 is a clinical-stage potent, selective, orally administered non-bile acid FXR agonist being developed as a novel therapeutic approach for IBD.
  • FXR314 broadly improved measures of epithelial barrier function in a subset of donors, and fibrotic markers in all Crohn’s disease donors.
  • In ulcerative colitis, FXR314 improved epithelial barrier function and fibrotic activity in all donors.
  • Organovo plans to begin enrollment for a proof-of-concept Phase 2 ulcerative colitis study in 2024, with targeted completion in 2025.

Abivax to host KOL Investor Event to review phase 2b clinical data and phase 3 trial design for obefazimod in patients with moderately to severely active ulcerative colitis on February 6, 2024

Retrieved on: 
Wednesday, January 24, 2024
Pediatrics, Northwestern University, Patient, Associate, UC, Personalized medicine, Nutrition, Euronext Paris, Division, Hepatology, Therapy, Ulcerative colitis, KOL, EST, Pharmaceutical industry

The event will feature Marla Dubinsky, MD, and Parambir Dulai, MD.

Key Points: 
  • The event will feature Marla Dubinsky, MD, and Parambir Dulai, MD.
  • Along with Abivax’s management, they will be discussing the unmet medical need and current treatment landscape for patients suffering from ulcerative colitis (UC).
  • She is also Chief of the Division of Pediatric GI and Nutrition at the Mount Sinai Kravis Children’s Hospital.
  • He serves as the Director of GI Clinical Trials and Precision Medicine, as well as Director of the Digestive Health Foundation Biorepository.

Abivax provides 2024 strategic outlook and lays out key milestones over next 12 months

Retrieved on: 
Monday, January 22, 2024
Patient, IBD, Gastrointestinal disease, Euronext Paris, IND, Safety, Ulcerative colitis, IPO, Congress, FDA, A12, Therapy, Colitis, Pharmaceutical industry

Our US office has recently been opened and we have completed the recruitment of a very experienced team with a particular focus in the US.

Key Points: 
  • Our US office has recently been opened and we have completed the recruitment of a very experienced team with a particular focus in the US.
  • Recruitment into both induction trials, ABTECT-1 and ABTECT-2, is ongoing in all designated regions.
  • No new safety signals were detected in UC patients treated up to five years with oral, once-daily obefazimod.
  • Selection of the first follow-on drug candidate is expected in Q3 2024 to further strengthen the Abivax pipeline.

Enthera Pharmaceuticals Appoints Lisa M. Olson as CEO and Announces Clinical Trial Progress with Ent001

Retrieved on: 
Tuesday, January 23, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Patient, UC, Colitis, T1D, IGFBP, IBD, SAD, Disease, Medication, Inflammation, Safety, Therapy, Biomarker, Ulcerative colitis, Inflammatory Bowel Diseases, AbbVie, Pharmacokinetics, Pharmaceutical industry

Dr. Olson joins Enthera’s management team with over two decades of leadership experience in the biopharmaceutical industry including a successful career at AbbVie.

Key Points: 
  • Dr. Olson joins Enthera’s management team with over two decades of leadership experience in the biopharmaceutical industry including a successful career at AbbVie.
  • “We are entering the new year with positive momentum in Enthera’s corporate and clinical evolution with Lisa’s appointment as CEO and important progress with Ent001.
  • We are thrilled to have her join as CEO,” said Silvano Spinelli, Chairman of the Enthera Board of Directors.
  • Based on this, Enthera has initiated a multiple ascending dose (MAD) Phase 1b clinical trial in patients with moderately to severely active UC.

OSE Immunotherapeutics Highlights Clinical Portfolio Advancements and Provides 2024 Outlook

Retrieved on: 
Friday, January 19, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Journal of Immunology, HCC, ICI, CD47, Cancer, EMA, Journal, Pembrolizumab, IL-7, Kidney transplantation, Acute lymphoblastic leukemia, Annals of Oncology, Nivolumab, Fortification, ESMO, Hepatocellular carcinoma, Safety, Inflammation, Ulcerative colitis, Patent, Ovarian cancer, Failure, Survival, Immunotherapy, Boehringer Ingelheim, Committee, Myelocyte, Oncology, Patient, European Medicines Agency, ALL, Partnership, Lung cancer, Head, Pancreatic cancer, Phase II, FDA, Clinical trial, FOLFIRI, Pharmaceutical industry

OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) updates on its clinical portfolio advancements and provides 2024 outlook.

Key Points: 
  • OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) updates on its clinical portfolio advancements and provides 2024 outlook.
  • Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: “The Company has a broad portfolio of 5 products in clinical development with significant advances reached in 2023 and key milestones expected in 2024.
  • Our shared ambition at OSE is to create value by leading our two advanced assets in phase 2 and phase 3 to a clinical inflection point allowing a structuring agreement.
  • Thus, from Q1 2024, the Company could have validated doses and therapeutic regimens to consider the implementation of possible other clinical trials.

Biora Therapeutics Provides Outlook for 2024

Retrieved on: 
Tuesday, January 16, 2024
Patient, Therapy, Research, Animal, UC, GLP, SAN, Partnership, SAD, Human, Ulcerative colitis, Aviation, AstraZeneca, Trial of the century, Pharmaceutical industry

SAN DIEGO, Jan. 16, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today provided guidance on anticipated milestones during 2024.

Key Points: 
  • SAN DIEGO, Jan. 16, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today provided guidance on anticipated milestones during 2024.
  • “In 2023, we completed the transformation of the company, focusing on strong execution which laid the foundation for significant value inflection in the coming months,” said Adi Mohanty, Chief Executive Officer of Biora Therapeutics.
  • “We begin 2024 in the clinic with our phase 1 study for BT-600, which will be a major de-risking step in the development of our NaviCap™ platform.
  • We already have data on the device alone in humans, and tofacitinib is already used to treat UC.

EQS-News: Evotec and Crohn´s & Colitis Foundation enter agreement to advance drug discovery for novel IBD therapies

Retrieved on: 
Saturday, January 13, 2024
Senior, Translation, Patient, Frankfurt Stock Exchange, Therapy, Research, MDAX, EVO, IBD, Inflammatory bowel disease, Drug discovery, Fibrosis, Doctor of Philosophy, Ulcerative colitis, Pharmaceutical industry

Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) today announced that the Company has joined forces with the Crohn’s & Colitis Foundation (“the Foundation”), the leading non-profit organisation focused on both research and patient support for inflammatory bowel disease (“IBD”), which includes Crohn’s disease and ulcerative colitis.

Key Points: 
  • Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) today announced that the Company has joined forces with the Crohn’s & Colitis Foundation (“the Foundation”), the leading non-profit organisation focused on both research and patient support for inflammatory bowel disease (“IBD”), which includes Crohn’s disease and ulcerative colitis.
  • Under the collaboration, Evotec joins forces with the Foundation’s IBD Therapeutics Incubator programme that facilitates collaboration between the Foundation, academic researchers, and industry partners to translate groundbreaking basic research that was performed by academic researchers and identified by the Foundation into medical innovations for IBD patients.
  • “We’re actually driving research from idea to therapeutic product opportunity.”
    “We’re excited to initiate these drug discovery projects with top-notch academic investigators and the experienced scientists at Evotec,” said Jennifer Swantek, PhD, Director of the Foundation’s IBD Therapeutics Incubator programme.
  • “We’re eager to deliver much needed, differentiated therapies to Crohn’s disease and ulcerative colitis patients as soon as possible.”
    No financial terms of the collaboration were disclosed.

Organovo To Present FXR314 IBD 3D Model Findings at Upcoming Crohn’s and Colitis Congress

Retrieved on: 
Tuesday, January 9, 2024
Biology, Fibrosis, Organovo, UC, SAN, Partnership, Tissue, IBD, Inflammatory bowel disease, Executive, Cirrhosis, Research and development, Disease, 3D, NASH, Colitis, Ulcerative colitis, FXR, Ulcer

The invited oral presentation, entitled “Evaluation of the clinical stage FXR agonist FXR314 in human primary cell 3D models of Crohn’s disease and ulcerative colitis”, will be made on Friday, January 26, 2024 at 3:00 PM PST by Dr. Fabrice Piu, Vice President, Research & Development.

Key Points: 
  • The invited oral presentation, entitled “Evaluation of the clinical stage FXR agonist FXR314 in human primary cell 3D models of Crohn’s disease and ulcerative colitis”, will be made on Friday, January 26, 2024 at 3:00 PM PST by Dr. Fabrice Piu, Vice President, Research & Development.
  • “We initially identified a strong benefit of FXR agonism in IBD using our internal 3D models, then moved towards development of what we believe to be a best-in-class FXR agonist, FXR314, to treat IBD,” said Keith Murphy, Organovo's Executive Chairman.
  • Organovo plans to begin enrollment for a proof-of-concept Phase 2 ulcerative colitis study in 1H 2024, with targeted completion in 1H 2025.
  • The drug’s additional promise in liver fibrosis and NASH makes it a strong candidate for development in that area through partnership collaborations with Organovo.

Palisade Bio Selected for Poster Presentation at the 2024 Crohn’s & Colitis Congress

Retrieved on: 
Tuesday, January 9, 2024
Therapy, Ulcerative colitis, Efficacy

Carlsbad, CA, Jan. 09, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a biopharmaceutical company focused on developing novel therapeutics for serious chronic gastrointestinal (GI) diseases, today announced that its abstract has been accepted for poster presentation at the Crohn’s & Colitis Congress being held January 25-27, 2024 in Las Vegas, NV.

Key Points: 
  • Carlsbad, CA, Jan. 09, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a biopharmaceutical company focused on developing novel therapeutics for serious chronic gastrointestinal (GI) diseases, today announced that its abstract has been accepted for poster presentation at the Crohn’s & Colitis Congress being held January 25-27, 2024 in Las Vegas, NV.
  • Details of the poster presentation are as follows:
    Poster Title: Local Bioactivation and Efficacy of PALI-2108: A Promising PDE4 Inhibitor Prodrug for Ulcerative Colitis Treatment

Biora Therapeutics Announces Initiation of Phase 1 Clinical Study of BT-600

Retrieved on: 
Monday, January 8, 2024
Trial of the century, MD, SAN, Therapy, Pharmacokinetics, Serum, Volunteering, SAD, Patient, Safety, Ulcerative colitis, Pharmaceutical industry

SAN DIEGO, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced initiation of its phase 1, first-in-human clinical study of BT-600 in healthy adult volunteers. BT-600 is a drug-device combination program consisting of the orally administered NaviCap™ device which delivers a unique, liquid formulation of tofacitinib to the colon for the potential treatment of moderate to severe ulcerative colitis.

Key Points: 
  • First-in-human trial of BT-600 drug-device combination, following multiple successful device-only human studies
    SAD/MAD study to evaluate safety and PK/PD of BT-600, including concentrations in colon tissue
    SAN DIEGO, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc .
  • (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced initiation of its phase 1, first-in-human clinical study of BT-600 in healthy adult volunteers.
  • We anticipate increased colonic tissue drug levels and reduced systemic levels compared with conventional oral tofacitinib.
  • The study, which is being conducted in the United States, consists of two parts.